A Study to Predict Post-Surgery Symptom Outcomes with the Use of a Preoperative Pessary
Overview
Tab Title Description
Study type
InterventionalDescribes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
Study IDs
Site IRB
- Rochester, Minnesota: 15-006186
NCT ID: NCT02680145
Sponsor Protocol Number: 15-006186
About this study
The goal of the study is to evaluate the change in pelvic floor symptoms with pessary use prior to reconstructive pelvic floor surgery for pelvic organ prolapse. Additionally, we will assess the impact that preoperative pessary use has on patient self-reported preparedness for surgery.
Participation eligibility
Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.
Inclusion Criteria
- Older than 18 years of age
- Has symptomatic pelvic organ prolapse
- Electing for surgical repair of pelvic organ prolapse (transvaginal or transabdominal) at least 7 days after office consultation
- Understand and have signed written informed consent for preoperative pessary placement
Exclusion Criteria
- Previous use of a pessary for pelvic organ prolapse
- Patients undergoing obliterative prolapse surgery (i.e. Colpocleisis)
- Scheduled for surgery for pelvic organ prolapse less than 7 days after office consultation
- Have an isolated rectocele
- Have allergies to both latex and silicone
- Have an active pelvic infection
Participating Mayo Clinic locations
Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.
Mayo Clinic Location |
Status |
|
Rochester, Minn.
Mayo Clinic principal investigator John Occhino, M.D., M.S. |
Closed for enrollment |
|
More information
Publications
Publications are currently not available